Acute Renal Injury Associated Contrast in Intensive Care Unit Patients

Acute Renal Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807195
• Other study ID #: 4-2012-0922
• Status: Completed
• Phase: N/A
• First received: March 6, 2013
• Last updated: June 5, 2014
• Start date: February 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Generally, a contrast medium is used when performing a CT scan or radiographic tests such as angiography because it heightens image clarity and can increase diagnosis accuracy. Despite these advantages, contrast media can cause allergic reactions in the body or a decline in renal function. Therefore, they should be handled carefully and explained sufficiently to the patient. For intensive care patients, the use of contrast agents has been revealed as a major cause of acute renal damage, and many studies have investigated this complication by examining incidence rates and prevention strategies. Hypothesis: Among intensive care patients, the group in which a contrast medium was used will have a higher risk of renal function decline compared with the group in which a contrast medium was not used, and, hence, the use of contrast media becomes a cause of renal function deterioration. Categorizing patients with renal function decline according to the new RIFLE criteria can have an association with the prognosis of intensive care patients, such as hospitalization period and death rate, which can promote faster intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 886
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was used in the intensive care unit were examined.

Exclusion Criteria:

• For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was not used in the intensive care unit were examined.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Injury

Intervention

Other:
• contrast medium usage

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of acute renal damage associated with contrast media in intensive care patients	The occurrence of acute renal damage was examined, and these patients were compared with the group that did not develop acute renal damage to investigate whether the use of contrast agents acts as an independent variable. In addition, the RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media.	each time evaluation of contrast medium usage	No